An observational study in Malignant Ascites, sponsored by Sequana Medical N.V.. Withdrawn at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-10.
Sponsored by Sequana Medical N.V. · Observational
ProMAS is a prospective post-marketing, single-arm study to assess performance and safety of the Alfapump® system in the treatment of patients with malignant ascites. The study aims to enroll 40 patients in up to 8 sites in Europe.
The Prospective Malignant Ascites Alfapump® study is a single-arm, prospective study to evaluate the performance and safety of the Alfapump® system in the treatment of patients with malignant ascites. The Alfapump® system is a fully implantable programmable pump, able to move ascitic fluid from the peritoneal cavity to the bladder via 2 catheters. The Alfapump® has obtained CE (Conformité Européenne) mark approval for the indication of malignant ascites. The primary objective of the study is to assess the performance of the system to remove ascites. Secondary objectives are to evaluate the safety and tolerability of the Alfapump® in the treatment of malignant ascites for a total follow-up period of 9 months, and to evaluate quality of life (QoL) by reduction or elimination of paracentesis requirement. Furthermore the study includes an exploratory scientific objective as to feasibility to obtain 'liquid biopsy' samples suitable for analysis in a non-invasive way after Alfapump® implantation. 40 patients with malignant ascites will be enrolled in up to 8 sites in Europe (Belgium, United Kingdom, Switzerland). Specific sub-analysis of data from patients with gynecological (ovarian) cancer is planned.
252 studies on the registry are indexed under Ascites; 52 are open to participants now.
Browse Ascites studies →Sequana Medical N.V. is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Investigators will be asked to enrol subjects meeting the inclusion and exclusion criteria .This study population is highly palliating with overall limited prognosis and significant comorbidities and possibly reduced performance status. Subjects must be under the care of an oncologist specialised in their disease. In the case of hepatic involvement, a hepatologist, and in the case of ovarian or breast cancer a gynaecologic oncologist accustomed to managing subjects with advanced malignancy. Subjects will be enrolled into the trial from the clinical practices of the investigators. Suitable subjects will undergo screening, including detailed medical history, paracentesis history and blood tests, to ensure compliance with study inclusion / exclusion criteria.
6.Subject has a life expectancy of ≥3 months as assessed by the treating physician, and is receiving or intended to receive anticancer therapy.
7.Subject has the ability to comply with study procedures, including all follow-up visits at implanting centre when required, and ability to perform subject-required system tasks (charging). A subject with a caregiver who can comply with the study procedures and to perform the tasks required for appropriate pump function is allowed as well.
Exclusion Criteria:
active implantable device for treatment of malignant ascites
Monthly therapeutic paracentesis frequency up to 3 months
Monthly therapeutic paracentesis frequency up to 3 months compared to the baseline therapeutic paracentesis frequency. The monthly therapeutic paracentesis frequency up to 3 months is defined as the average rate of therapeutic paracenteses during month 1, 2 and 3 post-implantation. Baseline therapeutic paracentesis frequency is defined as the average rate of therapeutic paracentesis in the 3 months prior to pump implantation.
Time frame: 3 months post-implantation
Monthly therapeutic paracentesis frequency up to 6 months
Monthly therapeutic paracentesis frequency up to 6 months compared to the baseline therapeutic paracentesis frequency. The monthly therapeutic paracentesis frequency at 6 months is defined as the average rate of therapeutic paracenteses during months 1 to 6 Baseline therapeutic paracentesis frequency is defined as the average rate of therapeutic paracentesis in the 3 months prior to pump implantation.
Time frame: 6 months post-implantation
Safety outcome: free survival
Therapeutic paracentesis free survival after Alfapump® implantation
Time frame: Time (days) to first paracentesis after implantation through 270 days post implantation
Efficacy outcome- Assessment of changes in Quality of Life
Changes in Quality of life after Alfapump® implantation, measured with validated EORTC cancer related Quality of life Questionnaire-CR29 (ColoRectal 29 questions) in subjects with colorectal malignancy.
Time frame: at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline
Efficacy outcome- Assessment of changes in Quality of Life
Changes in Quality of life after Alfapump® implantation assessed with validated FACIT-AI 5Ascites Index) ascites related quality of life questionnaire in all subjects enrolled in the study.
Time frame: at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline
Efficacy outcome- Assessment of changes in Quality of Life
Changes in Quality of life after Alfapump® implantation, measured with validated EORTC-cancer related Quality of life questionnaire-OV28 (OVarian 28 questions), in subjects with a gynaecological malignancy.
Time frame: at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline
Nutritional status outcome
Change in nutritional status assessed by Psoas muscle measurement
Time frame: at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline
Nutritional status outcome
Change in nutritional status assessed by changes in serum Zinc
Time frame: at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline
Nutritional status outcome
Change in nutritional status assessed by changes in serum pre-albumin
Time frame: at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline
Nutritional status outcome
Change in nutritional status assessed by changes in serum phosphate
Time frame: at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline
Nutritional status outcome
Change in nutritional status assessed by changes in serum potassium
Time frame: at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline
Nutritional status outcome
Change in nutritional status assessed by changes in serum albumin
Time frame: at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline
Pump performance
Total Monthly volume of ascitic fluid removed (sum of volumes removed during each month via either Alfapump® and via therapeutic paracentesis)
Time frame: at 1-month, 3-month, 6-month and 9-month follow-up
Pump performance outcome - pump survival
Pump survival through study completion, up to 270 days post-pump implantation
Time frame: Time (days) from implantation until explantation due to technical causes through study completion up to 270 days post-pump implantation
Pump performance outcome - pump survival
Pump survival through study completion, up to 270 days post-implantation
Time frame: Time (days) from implantation until first exchange due to technical causes through study completion up to 270 days post-pump implantation
Pump performance outcome
Frequency of hospitalisations following Alfapump® implantation through study completion up to 270 days post-pump implantation
Time frame: through study completion up to 270 days post-pump implantation
Pump performance outcome
Duration of hospitalisations following Alfapump® implantation through study completion up to 270 days post-pump implantation
Time frame: throug study completion up to to 270 days post-pump implantation
Safety outcome - subject survival
Subject overall survival after Alfapump® implantation through study completion up to 270 days post-pump implantation
Time frame: Time (days) until exitus through study completion up to 270 days post-pump implantation
Safety outcome- Bladder metastasis: Freedom from metastatic bladder wall infiltration
Freedom from metastatic bladder wall infiltration as assessed by cystoscopy
Time frame: at 6-month follow-up
Safety outcome- Worsening of renal function
Incidence of subjects suffering Renal function deterioration, defined as a rise in serum creatinine of ≥50% or ≥0.3mg/dl .
Time frame: at 3-month, 6-month and 9-month follow-up compared to baseline
Safety outcome- Incidence of device related infection
Incidence of Device-related infections following pump-implantation
Time frame: at 3-month, 6-month and 9-month follow-up
Safety outcome- Incidence of Procedure related events
Incidence of Procedure related adverse events
Time frame: At 1 month follow-up.
Safety outcome- Incidence of Device related events
Incidence of any Device-related adverse events
Time frame: at 3-month, 6-month and 9-month follow-up
Device failure
Incidence of device failure resulting in re-intervention (Revision, exchange or explantation) through study completion up to 270 days post-pump implantation
Time frame: Through study completion up to 270 days post-pump implantation
Exploratory outcome- liquid biopsies
Incidence of successful acquisition of ascitic fluid samples appropriate for oncological analysis via Alfapump® function
Time frame: 2-days, 7-days, 3-months, 6-months and 9-months post implant
Exploratory outcome - anticancer treatment
Incidence of Initiation of new / change to existing anticancer treatment through study completion up to 270 days post-pump implantation
Time frame: Time (days) to event through study completion up to 270 days post-pump implantation
Plan to share: No — No individual participant data will be shared with other researchers
This study is withdrawn, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sequana Medical N.V.